This study will use electronic health services databases to describe the usage patterns of dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the extent and proportion of patients with characteristics suggestive of the use of PRILIGY within, versus outside of the intended use population.

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:

The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population. [ Time Frame: For up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of patients prescribed PRILIGY who have conditions or use medications that are described in the special warnings and precautions section of the PRILIGY Summary of Product Characteristics (SPC) [ Time Frame: For up to 1 year ] [ Designated as safety issue: No ]

The number of patients prescribed PRILIGY who are at risk for bleeding due to current use of nonsteroidal anti-inflammatory drugs (NSAID's) and warfarin. [ Time Frame: For up to 1 year ] [ Designated as safety issue: No ]

The number of patients prescribed PRILIGY who do not have a diagnosis suggestive of the approved indication. [ Time Frame: For up to 1 year ] [ Designated as safety issue: No ]

PRILIGY (dapoxetine hydrochloride) The study will observe characteristics of the patients to whom PRILIGY 30-mg and 60-mg tablets are prescribed in Germany by general practitioners and (separately) by urologists and in Italy by urologists

Drug: PRILIGY (dapoxetine hydrochloride)

The study will observe characteristics of the patients to whom PRILIGY 30-mg and 60-mg tablets are prescribed in Germany by general practitioners and (separately) by urologists, and in Italy by urologists

Detailed Description:

This study will use anonymized (nameless) patient data from electronic health services databases in Germany and Italy to describe the proportion of PRILIGY (dapoxetine hydrochloride) usage among those patients with characteristics suggestive of the use of PRILIGY within versus outside (eg, those with contraindications) of the intended use (IU) population. This is an observational study; no investigational drug will be administered.

Eligibility

Ages Eligible for Study:

Child, Adult, Senior

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Male patients prescribed PRILIGY by physicians who contributed data to the CSD electronic health services databases for German urologists, German general practitioners, or Italian general practitioners.

Criteria

Inclusion Criteria:

Received a prescription for PRILIGY

Treated by physicians who contributed data to the IMS Disease Analyzer database for Germany and Thales database for Italy

Exclusion Criteria:

Age not specified

Sex not specified as "male

" Fewer than 6 months (183 days) of history in the electronic health services databases before receiving the first prescription for PRILIGY (At least 6 months of history in the database is not required for the patients of the German urologists).

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273545